Phase 4
Completed N=179
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Source: ClinicalTrials.gov NCT02340000 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms") — 33; 31; 22; 33 Participants
◆ Published Evidence
Emerging
10citations · ~1 / year
High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial.
Summary
The aim is to determine if high-dose amoxicillin/clavulanate is more effective than standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at a primary care office.
Linked Publications
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High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms") |
33; 31; 22; 33 | — |
| SECONDARY SNOT-16 - Day 3 |
.75; .87; .91; .97 | — |
| SECONDARY Subjective Improvement - Day 10 |
63; 59; 35; 40 | — |
| SECONDARY SNOT-16 - Day 10 |
1.32; 1.48; 1.37; 1.40 | — |
| SECONDARY Nasal Colonization With Resistant Bacteria |
139; 32; 25; 9; 9; 7 | — |
| SECONDARY Willingness to Take the Study Antibiotic in the Future |
8; 11; 5; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult 18 or over
- Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
- Clinician and participant chose to start antibiotic treatment
Exclusion Criteria
- Previously enrolled in the study
- Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
- Specific medication concerns: lactating (since safety of clavulanate unknown); taking allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash with amoxicillin); chronic kidney disease with glomerular filtration rate < 30; significant hepatic impairment; history of antibiotic-associated colitis
- Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
- Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin within the past month (risk of penicillin-resistant pneumococci), very ill patient (though not ill enough to send to hospital); immunocompromise
- Need to hospitalize the patient
Data sourced from ClinicalTrials.gov (NCT02340000) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.